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NCT07718906
Neuromodulation for Behavioral Changes in Neurological Disorders
Conditions: Dementia
Sex: All
Ages: 45 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: West Virginia University
Location: WVU Rockefeller Neuroscience Institute Morgantown West Virginia
Summary
The purpose of this study is to see if a focused ultrasound neuromodulation can be safely and effectively used to treat symptoms of emotional dysregulation such as agitation, irritability and anxiety
Eligibility Criteria
* Age 45-80 years at time of enrollment.
* Diagnosis of probable mild-stage neurodegenerative dementia, including Alzheimer's disease (AD), frontotemporal dementia (FTD, including behavioral variant and language variant), or dementia with Lewy bodies (LBD), based on established consensus clinical criteria.
* Presence of clinically meaningful (in treatment for or recommended for the symptoms) neuropsychiatric or behavioral symptoms including but not limited to anxiety, agitation, depression, irritability, apathy, or disinhibition
* Able to undergo MRI scanning
* Adequate auditory and visual abilities to complete study procedures as determined by the investigator.
* Availability of a study partner (legally authorized representative, caregiver, or family member) who has regular contact with the participant and can provide collateral information and assist with assessments.
* Ability to provide informed consent, or assent with legally authorized representative (LAR) consent in accordance with WVU IRB policy and applicable West Virginia law. .Currently under the care of a licensed physician, psychiatrist, or neurologist, and agrees to allow communication between investigators/study staff and healthcare providers for purposes of eligibility confirmation and safety monitoring.
EXCLUSION CRITERIA
* Moderate to severe dementia (i.e., beyond mild stage).
* Clinically significant MRI abnormality that may jeopardize participant safety, study conduct, or confound diagnostic assessments.
* History of clinically significant neurological disorder other than the qualifying dementia diagnosis that could confound evaluation or increase risk.
* Major psychiatric disorder that would interfere with participation or safety, including psychosis, active suicidal ideation, or severe mood/anxiety disorder requiring immediate intervention.
* Elevated suicide risk with History of medically verified suicide attempt within the past year.
* Use of medications that significantly lower the seizure threshold or interfere with neuromodulation safety, as determined by the study physician.
* Use of investigational drugs or participation in another interventional clinical trial within 30 days prior to screening.
* Any condition that, in the opinion of the investigator, would interfere with study participation, safety, or interpretation of results.
Source: ClinicalTrials.gov (NCT07718906). StuddyBuddy aggregates publicly available trial information.